Venlafaxine Hydrochloride

Treats major depressive disorder (MDD). NDA 22104, held by Osmotica Pharm US. Venlafaxine Hydrochloride.

As of Nov 13, 2026, NDA 22104 (Venlafaxine Hydrochloride), held by Osmotica Pharm US, was first approved by FDA on May 20, 2008, with 13 approved supplements and 0 published complete response letters.

First approved: May 20, 2008
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Venlafaxine Extended Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) Social Anxiety Disorder (SAD) 1.1 Major Depressive Disorder Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
May 20, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter

Products

4 strengths and forms


Venlafaxine HydrochlorideEQ 37.5MG BASE · tablet, extended release;oral	Venlafaxine Hydrochloride	RxReference drug
Venlafaxine HydrochlorideEQ 75MG BASE · tablet, extended release;oral	Venlafaxine Hydrochloride	RxReference drug
Venlafaxine HydrochlorideEQ 150MG BASE · tablet, extended release;oral	Venlafaxine Hydrochloride	RxReference drug
Venlafaxine HydrochlorideEQ 225MG BASE · tablet, extended release;oral	Venlafaxine Hydrochloride	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 23Labeling · Standard review	Approved	Label Medication Guide Letter
Sep 20, 2021	Supplement 21Labeling · Standard review	Approved	Label Letter
Dec 19, 2017	Supplement 16Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 15Labeling	Approved	Letter Label
Dec 14, 2016	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 21, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 24, 2016	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 10Labeling	Approved	Label Letter
Dec 11, 2012	Supplement 9Labeling · Standard review	Approved	Label Letter
Jul 31, 2012	Supplement 7REMS	Approved	Letter
May 2, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Feb 27, 2009	Supplement 2Manufacturing	Approved	Label Letter
Jan 30, 2009	Supplement 3Labeling · Standard review	Approved	Label Letter
May 20, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter

Identifiers

Application: NDA 22104
Drugs@FDA: Overview at FDA
Company: Osmotica Pharmaceuticals US

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters